đź“‹ FDA Reference
schneider guider softip guiding catheters
Boston Scientific Scimed
Summary: The Schneider Guider Softip Guiding Catheters are used in interventional cardiology and radiology to facilitate the placement of stents and other devices within the venous system. They are typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K981413 ↗
Decision Date
May 13, 1998
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Schneider Guider Softip Guiding Catheters were cleared by the FDA through the 510(k) pathway on May 13, 1998. Manufactured by Boston Scientific Scimed, this device is classified as a Class II medical device.
What It Is
The Schneider Guider Softip Guiding Catheters are specialized catheters designed to provide support and guidance for the delivery of interventional devices, such as stents, into the venous system. These catheters feature a soft tip to minimize trauma to the vessel walls during navigation. They are constructed to offer flexibility and torque control, aiding in precise placement of devices.
Clinical Applications
These guiding catheters are commonly used in procedures involving venous stenting, particularly in cases of venous obstruction or thrombosis. They are essential tools in interventional cardiology and radiology, often used in hospital settings by specialists treating conditions such as deep vein thrombosis or venous insufficiency. The catheters help in navigating complex vascular anatomy, ensuring accurate device deployment.
Indications for Use
The FDA indications for these catheters include their use in facilitating the placement of stents and other interventional devices within the venous system. They are suitable for patients requiring venous interventions due to conditions like blockages or narrowing of the veins.
Practical Considerations
These catheters come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with a range of interventional devices and should be selected based on the specific requirements of the procedure. Proper technique in handling and navigation is crucial to minimize vessel trauma.
Frequently Asked Questions
What is Schneider Guider Softip Guiding Catheters used for?
They are used to guide and support the placement of stents and other devices in the venous system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The catheters are indicated for use in guiding the placement of stents and other devices within the venous system, particularly in cases of venous obstruction or narrowing.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.